Dataset Information

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial.

ABSTRACT:

Background

There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors.

Objectives

This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study.

Design

3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120).

Intervention

Girls aged 11-12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities.

Economic outcome measures

Programme costs and girls' preferences for attributes of dance and preferences for competing leisure time activities were measured.

Results

The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was $70.90, £44.31 and €51.84 in 2010-2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h.

Conclusions

This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated.

SUBMITTER: Powell JE

PROVIDER: S-EPMC3884756 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Publications

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial.

Powell Jane E JE Carroll Fran E FE Sebire Simon J SJ Haase Anne M AM Jago Russell R

BMJ open 20131220 12

<h4>Background</h4>There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors.<h4>Objectives</h4>This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study.<h4>Design</h4>3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, U ...[more]

PMID: 24362013

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Project description:ObjectivesTo systematically review published pretrial qualitative research studies and explore how their findings were used to inform recruitment and retention processes in full-scale trials.DesignQualitative evidence synthesis using thematic analysis.Data sources and eligibility criteriaWe conducted a comprehensive search of databases; Dissertation Abstracts International, CINAHL, Embase, MEDLINE, Sociological Abstracts and PsycINFO. We included all reports of pretrial qualitative data on recruitment and retention in clinical trials up to March 2018.Data extraction and synthesisTwo authors independently extracted data using a predefined data extraction form that captured study aims, design, methodological approach and main findings, including barriers and facilitators to recruitment and or retention. The synthesis was undertaken using Thomas and Harden's thematic synthesis method and reported following the Enhancing Transparency in Reporting the Synthesis of Qualitative Research guidelines. Confidence was assessed using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach.ResultsThirty-five papers (connected to 31 feasibility studies) from three different countries, published between 2010 and 2017 were included. All studies were embedded in pilot or feasibility studies to inform design aspects in preparation for a subsequent full-scale trial. Twelve themes were identified as recruitment barriers and three as recruitment facilitators. Two themes were identified as barriers for retention and none as retention facilitators. The findings from qualitative research in feasibility or pilot trials are often not explicitly linked to proposed changes to the recruitment and retention strategies to be used in the future or planned full-scale trial.ConclusionsMany trial teams do pretrial qualitative work with the aim of improving recruitment and retention in future full-scale trials. Just over half of all reports of such work do not clearly show how their findings will change the recruitment and retention strategy of the future trial. The scope of pretrial work needs to expand beyond looking for problems and also look for what might help and spend more time on retention.

Project description:BACKGROUND:Chronic kidney disease (CKD) is a progressive condition that leads to irreversible damage to the kidneys and is associated with an increased incidence of cardiovascular events and mortality. As novel interventions become available, estimates of economic and clinical outcomes are needed to guide payer reimbursement decisions. OBJECTIVE:The aim of the present study was to systematically review published economic models that simulated long-term outcomes of kidney disease to inform cost-effectiveness evaluations of CKD treatments. METHODS:The review was conducted across four databases (MEDLINE, Embase, the Cochrane library and EconLit) and health technology assessment agency websites. Relevant information on each model was extracted. Transition and mortality rates were also extracted to assess the choice of model parameterisation on disease progression by simulating patient's time with end-stage renal disease (ESRD) and time to ESRD/death. The incorporation of cardiovascular disease in a population with CKD was qualitatively assessed across identified models. RESULTS:The search identified 101 models that met the criteria for inclusion. Models were classified into CKD models (n = 13), diabetes models with nephropathy (n = 48), ESRD-only models (n = 33) and cardiovascular models with CKD components (n = 7). Typically, published models utilised frameworks based on either (estimated or measured) glomerular filtration rate (GFR) or albuminuria, in line with clinical guideline recommendations for the diagnosis and monitoring of CKD. Generally, two core structures were identified, either a microsimulation model involving albuminuria or a Markov model utilising CKD stages and a linear GFR decline (although further variations on these model structures were also identified). Analysis of parameter variability in CKD disease progression suggested that mean time to ESRD/death was relatively consistent across model types (CKD models 28.2 years; diabetes models with nephropathy 24.6 years). When evaluating time with ESRD, CKD models predicted extended ESRD survival over diabetes models with nephropathy (mean time with ESRD 8.0 vs. 3.8 years). DISCUSSION:This review provides an overview of how CKD is typically modelled. While common frameworks were identified, model structure varied, and no single model type was used for the modelling of patients with CKD. In addition, many of the current methods did not explicitly consider patient heterogeneity or underlying disease aetiology, except for diabetes. However, the variability of individual patients' GFR and albuminuria trajectories perhaps provides rationale for a model structure designed around the prediction of individual patients' GFR trajectories. Frameworks of future CKD models should be informed and justified based on clinical rationale and availability of data to ensure validity of model results. In addition, further clinical and observational research is warranted to provide a better understanding of prognostic factors and data sources to improve economic modelling accuracy in CKD.

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Project description:BackgroundDuring the COVID-19 epidemic, opportunities for social interaction and physical activity among older people are decreasing, which may have a negative impact on their health. As a solution, a web-based group exercise program provided through a videoconferencing platform would be useful. As a web-based exercise program that older adults can easily, safely, and enjoyably perform at home, we developed a short-duration, light-intensity aerobic dance exercise program. Before studying the effectiveness of this exercise program, its characteristics, such as feasibility, safety, enjoyment, and system usability, should be examined among older adults.ObjectiveThis pilot study aimed to examine the feasibility, safety, and enjoyment of a web-based aerobic dance exercise program and the usability of a web-based exercise delivery system using a videoconferencing platform for older adults.MethodsThis study was designed as a prospective single-arm pilot study. A total of 16 older adults participated in an 8-week web-based aerobic dance program held every morning (8:30 AM to 8:50 AM) on weekdays at home. Retention and adherence rates were measured for the program's feasibility. Safety was assessed by the heart rate reserve, an index of exercise intensity calculated from heart rate, and the number of adverse events during exercise sessions. Enjoyment of this exercise program was assessed by an 11-point Likert scale ranging from 0 (not enjoyable at all) to 10 (extremely enjoyable) obtained through telephone interviews after the first-, third-, sixth-, and eighth-week intervention. For usability, the ease of the videoconferencing platform system was assessed through telephone interviews after the intervention.ResultsA female participant with hypertension dropped out in the second week because of the continuously reported high blood pressure (≥180 mmHg) before attending the exercise session in the first week. Therefore, the retention rate was 93.8% (15/16). Among the remaining participants, the median (IQR) overall adherence rate was 97.4% (94.7-100). Regarding safety, the mean (SD) heart rate reserve during the aerobic dance exercise was 29.8% (6.8%), showing that the exercise was relatively safe with very light to light intensity. There were no adverse events during the exercise session. The enjoyment score (0-10 points) significantly increased from the first (6.7 [1.7]) to sixth (8.2 [1.3]) and eighth week (8.5 [1.3]). Regarding usability, 11 participants reported difficulties at the beginning, such as basic touch panel operations and the use of unfamiliar applications; however, all got accustomed to it and subsequently reported no difficulty.ConclusionsThis study showed high feasibility, enjoyment, and safety of the web-based aerobic dance exercise program in older adults, and the web-based exercise delivery system may have areas for improvement, albeit without serious problems. Our web-based aerobic dance exercise program may contribute to an increase in physical and social activities among older adults.

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Dataset Information

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial.

Background

Objectives

Design

Intervention

Economic outcome measures

Results

Conclusions

Publications

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial.

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